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Family Model Diabetes Self-Management Education and Support in the RMI

This study is testing a program called "Family Model Diabetes Self-Management Education and Support" to help people with type 2 diabetes. This program involves you and at least one family member learning together in a faith-based organization. Researchers want to see if this program helps improve blood sugar control, measured by your HbA1c (a blood test that shows your average blood sugar over 2-3 months). You can join if you are 18 or older, self-identify as Marshallese, have type 2 diabetes (HbA1c 6.5% or higher), and have a family member willing to participate. The study aims to enroll 288 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with a wait-list control group, meaning some participants will receive the intervention later. It plans to enroll 288 participants.
What's involved
Participants will receive a culturally adapted family model diabetes self-management education and support. Some participants will wait approximately 12 weeks before receiving the intervention. Your HbA1c will be measured at the start, immediately after the intervention, and then 4 and 12 months later.
Compensation
Not stated in the trial record.
Follow-up
Your blood sugar control (HbA1c) will be monitored for 12 months after the intervention.

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NCT05502016

Family Model DSME in FBOs in the RMI

Recruiting
NAAges 18+InterventionalSupportive care
University of Arkansas
~288 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:Family Model Diabetes Self-Management Education and SupportFamily Model Diabetes Self-Management Education and Support (Wait-list)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glycemic control, measured by change in mean HbA1c (%) from baseline
Measured over Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention

Conditions

Diabetes Mellitus, Type 2

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Arkansas1

Study leadership

  • Pearl McElfish, PhD · PRINCIPAL_INVESTIGATOR · University of Arkansas

Who to contact

Betsy O'Connor, MA
[email protected]
479-713-8000
Email the study team

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Eligibility criteria

Inclusion

self-reported Marshallese
18 years of age or older
have type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%)
have at least one family member willing to take part in the study

Exclusion

has received diabetes self-management education in the past five years
has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
plans to move out of the geographic region

What this trial measures

  • Glycemic control, measured by change in mean HbA1c (%) from baselineBaseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention

    Point of care tests will be utilized to calculate HbA1c levels for each participant. The primary outcome measure is change in mean HbA1c (%) from baseline to immediate post-intervention, 4 months post-intervention, and 12 months post-intervention. Analyses will be adjusted for baseline HbA1c, sex, age, education, marital status, employment status, use of diabetes medications, and clustering of participants within churches.